Solifenacin Succinate

Indian pharmaceutical giants Glenmark, Sun Pharma, and Zydus are recalling over 40 products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA). Mumbai-based Glenmark initiated a Class II recall on March 13, 2025, for over 25 products, including Propafenone Hydrochloride capsules, Solifenacin Succinate tablets, and others, citing Current Good Manufacturing Practice (CGMP) deviations. Sun Pharma’s US subsidiary recalled 13,700 bottles of Gabapentin capsules, a seizure medication, on March 4, 2025, due to cross-contamination concerns. The company classified this as a Class III recall. Additionally, Zydus Pharmaceuticals (USA) pulled back 3,144 bottles of Chlorpromazine Hydrochloride tablets on April 3, 2025, after detecting N-Nitroso-Desmethyl Chlorpromazine impurities exceeding limits. This was categorized as a Class II recall. USFDA explained that Class II recalls address products with temporary or reversible health risks, while Class III recalls involve minimal health consequences. These recalls highlight ongoing challenges with quality control in the global pharmaceutical supply chain.

New Delhi: Drug makers Glenmark , Sun Pharma and Zydus are recalling products in the US for manufacturing issues, the US Food and Drug Administration ( USFDA ) said in its latest Enforcement Report. As per the US health regulator, Mumbai-based Glenmark is recalling over 25 products in the US market due to Current Good Manufacturing Practice (CGMP) deviations. New Jersey-based Glenmark Pharmaceuticals Inc is recalling affected lots of medications like Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets in America, the USFDA said. It is also recalling products like Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets and Rufinamide Tablets. The company initiated the Class II recall on March 13 this year. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal. A US-based subsidiary of Sun Pharma is recalling around 13,700 bottles of Gabapentin capsules, a medication used to treat and prevent seizures in people with epilepsy. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot due to 'Cross Contamination', the USFDA said. The company initiated the Class III recall on March 4, 2025. The US health regulator said Zydus Pharmaceuticals (USA) Inc is recalling 3,144 bottles of chlorproMAZINE Hydrochloride Tablets, USP 10 mg, a medication used to treat mental health conditions, like schizophrenia and bipolar disorder. The drug firm is recalling the affected lot due to CGMP deviations , the USFDA said. There was "presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit," it added. The company initiated the Class II recall on April 3, 2025.